UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of nutritional education on soft drink intake for children dwelling in a children's home
Title of the study (Brief title)	Examination of nutritional education on soft drink intake for children dwelling in a children's home
Region	Japan

Condition
Condition	Child
Classification by specialty	Not applicable Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examining of a healthy-food practice approach for soft drink intake
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amounts and Times of Soft drink intake 1week after nutrition education
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Group nutrition education(2time) and change of food environment
Interventions/Control_2	Group nutrition education(1time) and change of food environment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	13 years-old <=
Age-upper limit	18 years-old >=
Gender	Female
Key inclusion criteria	Junior and senior high school students children dwelling in a children's home
Key exclusion criteria	not selected
Target sample size	15

Research contact person
Name of lead principal investigator	Yukari Takemi
Organization	Kagawa nutrition university
Division name	Nutrition ecology
Address	3-9-21 Chiyoda, Sakado, Saitama
TEL	049-282-3721
Email	takemi@eiyo.ac.jp

Public contact
Name of contact person	Nozomi Takahashi
Organization	Chiba Local Government Health and Welfare Department
Division name	Health Promotion Support Division
Address	1-1 Ichiba-chou,chuo-ku, Chiba-city, Chiba
TEL	043-223-2667
Homepage URL
Email	n.sn2@pref.chiba.lg.jp

Sponsor
Institute	Kagawa nutrition university
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 21 Day
Anticipated trial start date	2016 Year 11 Month 28 Day
Last follow-up date	2017 Year 02 Month 01 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 23 Day
Last modified on	2017 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029225